A Playbook to Fully Utilise Closed Systems in Modern BioPharma Facilities

ISPE published the 2nd edition of the Volume 6 Baseline Guideline on Biopharmaceutical Manufacturing Facilities in 2013. This Baseline Guideline introduced a tangible concept of modern biopharma facilities that are based on closed processing. The concept has revolutionized the strategies used when designing biological API facilities. This presentation provides an introduction to the new Process Closure Playbook currently being drafted by a specialized BioPhorum group. The presentation also offers a definition of what is Grade D and what is CNC space used almost exclusively in facilities based on closed bioprocessing.